Herpes viruses are a group of DNA-containing animal viruses that produce disease, the best known of which is herpes. The viral disease, herpes, is characterized by eruptions of the skin or mucous membrane. Such eruptions are painful, unsightly, and associated with spread of the virus. Examples of various types of herpes viruses are herpes simplex or herpes zoster (responsible for the disease shingles).
The virus typically has two major phases, a dormant phase in which the disease state is not observable, and an active phase in which the virus "flare-up" or "breaks out" of the dormant phase to cause the characteristic herpes eruptions on the skin or mucous membranes of an individual.
During the active phase, an outbreak progresses through a number of sub-steps. First, the epidermis or mucous membrane in the area becoming involved in the outbreak becomes itchy or burns. Other symptoms, often associated with the early sub-steps of an outbreak, include tingling or numbness of the affected area. Second, the area becoming involved turns red and/or appears inflamed. Additionally, late in the second sub-step, subsurface lumps begin to form in the affected area. Next, in the third sub-step, blisters or vesicles begin to erupt or appear on the surface of the skin. Late in the third sub-step, the blisters or vesicles rupture, releasing a clear liquid and leaving an open sore at the site of the ruptured blister. This period of time, late in the third sub-step is sometimes referred to a "full bloom." Subsequently, in the forth sub-step, the outbreak progresses to a scab formation step. Later, in a fifth sub-step, the scab drops off, leaving tender new skin or mucous membrane. After the scab has fallen off, in the fifth step, the skin or mucous membrane of the involved area reverts to normal tissue.
A significant portion of the population is infected with Herpes virus and outbreaks in infected individuals occur intermittently throughout the remainder of their lives.
Acetylsalicylic acid is a well known drug, available as an over-the-counter pharmaceutical product in the United States. Acetylsalicylic acid is most commonly employed in an ingestible form for analgesic purposes. Acetylsalicylic acid has also been used as a surface supplied analgesic. The Nitardy patent, U.S. Pat. No. 1,915,945, suggests the use of acetylsalicylic acid in an ethyl ether and oil base for application to mucous membranes. The patent further suggests a synergistic action between acetylsalicylic acid and ethyl ether.
The Putt patent, U.S. Pat. No. 2,056,208, discloses that acetylsalicylic acid is known for application to mucous membranes of the mouth. The Putt patent also discloses the application of a liniment, including acetylsalicylic acid, to unbroken skin as a liniment for the treatment of inflammation or pain and to provide an analgesic effect. This patent further teaches that acetylsalicylic acid rapidly breaks down in water to salicylic acid and acetic acid. The rapid breakdown of acetylsalicylic acid is considered undesirable by Putt who suggests the need to use acetylsalicylic acid in a liquid form which does not allow a degradation or breakdown during the time required for absorption through the skin. The particular liniment disclosed is 30 grains in 1 ounce of glycerol oleate or other "unctuous base". The patent further discloses testing for absorption of acetylsalicylic acid by a ferric chloride reaction with any acetylsalicylic present in the urine and by fluorescence of skin which has absorbed acetylsalicylic acid.
The Campbell patent, U.S. Pat. No. 3,119,739 discloses the use of a composition, including acetylmethyl-salicylate, for pain relief and as an anodyne agent. The patent includes the statement that "it should be understood in no sense be regarded as a curative agent for the basic cause of the pain." The acetylmethyl-salicylate is used as 1-20% mixture in an inert pharmaceutical carrier. Solvents for the acetylmethyl-salicylate are preferred as the pharmaceutical carrier but suspensions or emulsions may also be used. Examples of suitable inert pharmaceutical carriers are ethanol, isopropanol and polyethylene glycol. The mixture is useful for treating insect bites and allergic reactions.
A popular over-the-counter lip ointment sold under the trademark BLISTEX by Blistex Incorporated of Oakbrook, Ill. 60521 contains allantoin (1%), camphor (0.5%) and phenol (0.5%) in an emollient base with petrolatum, lanolin, menthol, methyl salicylate, and other ingredients.
In spite of such prior art disclosing the use of acetyl-salicylic acid and related compounds such as methyl salicylate and acetyl methyl salicylic acid as analgesic and anti-inflammatory agents for both internal and external application, the prior art has not taught nor suggested use of externally applied acetylsalicylic acid as a treatment for herpes-type virus diseases. Further, the prior art has taught away from pharmaceutical preparations including both acetylsalicylic acid and water because of the fear of rapid degradation of the acetylsalicylic acid component into acetic acid and salicylic acid.